Powdered Latex Surgical Gloves Sterile, Sterile with Protein Content Labeling Claim

K113233 is the FDA 510(k) clearance record for POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM, a class I device, cleared for Shen Wei (Usa), Inc. on 2012-03-29 under FDA product code KGO (Surgeon'S Gloves). FDA's definition for product code KGO reads: "A surgeon's glove is a disposable device made of natural rubber latex or synthetic polymers that may or may not bear powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a...". FDA records list 58 510(k) clearances for Shen Wei (Usa), Inc., from 1989-05-25 to 2022-05-28. As of 2026-09-10, FDA records show no recalls naming K113233.